Internal audits are a critical pillar of every medical device Quality Management System — and a mandatory requirement under ISO 13485:2016 (Clause 8.2.4), MDSAP, and FDA QMSR (21 CFR Part 820). Poorly planned or inadequately documented audits are among the most common findings during third-party assessments and regulatory inspections.

This Audit Management SOP package gives your quality team a complete, audit-ready framework to plan, conduct, document, and follow up on internal audits — fully aligned with ISO 13485:2016, MDSAP, and FDA QMSR.

What’s Included

• P-03 Audit Management Procedure — step-by-step instructions covering audit program management, audit scheduling, auditor competence requirements, nonconformity handling, and record requirements
• F03-1 Audit Plan Template — pre-formatted, editable template to define audit scope, objectives, criteria, methods, and team assignments for each audit
• F03-2 Audit Report Template — structured template to document audit findings, objective evidence, nonconformities, and conclusions in a format ready for regulatory review
• F03-3 Annual Audit Planning Template — ready-to-use template to build and manage your annual internal audit program, ensuring full QMS coverage across all processes and departments

Who Is This For

Quality managers, internal audit leads, and management representatives at medical device companies seeking ISO 13485 certification, preparing for MDSAP audits, or maintaining FDA QMSR compliance.

Why This SOP and Not Starting from Scratch

Developing a compliant audit management procedure and all associated templates from scratch takes 6–10 hours of a regulatory professional’s time. This package is immediately usable, written by an experienced ISO 13485 Lead Auditor and former Notified Body auditor — reflecting current notified body and regulatory expectations across EU, US, and Canada.

✓ Instant download after purchase ✓ Fully editable Word format ✓ Compatible with ISO 13485:2016, MDSAP, FDA QMSR ✓ Updated April 2026 ✓ Used by quality teams across EU, US and Canada

Frequently Asked Questions

Q: Does this procedure cover both internal and supplier audits? A: The procedure is primarily designed for internal audits. It can be adapted for supplier audits, but a dedicated supplier audit procedure is recommended for full MDSAP and ISO 13485 compliance.

Q: Does the Annual Audit Planning Template help demonstrate full QMS coverage? A: Yes. The F03-3 template is structured to map all QMS processes and departments against your audit schedule, demonstrating systematic coverage — a key expectation in MDSAP and ISO 13485 audits.

Q: Is this suitable for companies with a small quality team? A: Yes. The procedure and templates are scalable and designed to work for quality teams of any size, including companies with a single quality manager.

Q: In what format are the documents delivered? A: All four documents are delivered in fully editable Microsoft Word (.docx) format.

Q: Does this cover FDA QMSR (21 CFR Part 820) requirements? A: Yes. The procedure is aligned with the FDA QMSR, which harmonizes with ISO 13485:2016 for internal audit requirements.